At high-volume medical facilities as blood bank centers, hospitals, and the like, blood is drawn from human donors in large quantities for processing and storage. In connection therewith, small volume specimens of the blood are withdrawn from the blood collection apparatus for necessary analysis. Blood withdrawal from humans exposes the medical worker to the risk of accidental needlestick injuries preparatory to connection of blood collection equipment to the donor in the unavoidable handling of used, unshielded, blood-contaminated needles.
In current practice, blood banking services, such as the American Red Cross among others, obtain, process, and store whole blood and blood components for a variety of medical uses such as transfusions and the like. Before any such blood can be used, however, all collected blood is analyzed to characterize its immune properties or so-called "blood type". Equally or more importantly, all blood must also be pre-tested for the presence of communicable disease pathogens, such as the hepatitis virus and the human immunodeficiency virus (HIV). As is well known, HIV is the causative agent of the uniformly fatal AIDS disease in humans, and thereby mandates the safest possible environment when handling human blood.
Blood collection as now commonly practiced utilizes a system including (1) a straight metal needle whose pointed end is inserted into a human donor to access a blood vessel wherein the needle usually includes a gripping portion bonded thereto to facilitate manual manipulation; (2) a length of flexible tubing in fluid communication at one end with the non-pointed proximal end of the needle; and, (3) one or more blood storage bags connected to the other end of the tubing. Additionally, helpful agents such as citrate-phosphate dextrose (CPD) are commonly included as anti-clotting additives within the collection system to prevent coagulation of the blood and permit it to remain in fluid condition.
Accordingly, traditional blood bag collection apparatus is thus a closed, sterile system in which the blood flows from the donor's blood vessel through the tubular metal needle, through the flexible tubing and into the blood storage bag, and in the use thereof for actual blood collection does not present a significant hazard to medical personnel.
As indicated, however, it is necessary to take a small sample of collected blood for analysis to insure the integrity and quality of the bag quantity. Customarily, to obtain the test sample, the medical or health care worker initially shuts off tubing flow as by a clamp, and then grips the needle with one hand by the enlarged grasping component thereof, removing the needle from the donor. Thereafter, the exposed needle tip, which is now blood-contaminated, is inserted through a rubber stopper or seal into a sample collection test tube, and the clamp is released to permit drawing of a sample of the collected blood reversely through the needle and into the test tube usually held in the other hand.
The open manipulation of the contaminated needle between withdrawal and sample securement presents unwanted hazards to personnel in the possibility of accidental needlestick injury.
Thus, the physical movement of the contaminated needle with one hand toward and in close proximity to the other hand holding the sample collector, there is a significant probability of self-inflicted injury. In effecting the sampling, the needle point may misalign with the rubber seal and puncture the worker's hand. Additionally, upon withdrawal of the inserted needle from the sample vial, the frictional resistance of the rubber stopper retarding needle withdrawal suddenly ceases as the needle pulls clear, and there is an involuntary tendency and reflex for the worker's hand holding the needle to recoil back toward the hand holding the test tube.
The actual rates and likelihood of needlestick injuries with such conventional blood collecting equipment have been well documented in a report appearing in the publication TRANSFUSIONS, Vol. 29, No. 8, October, 1989, pages 693-695, entitled "Needlestick Injuries in Blood Collection Staff--A Retrospective Analysis". Attempts to improve the present practice by using a guard mechanism to reduce the chances of accidentally puncturing the healthcare worker's fingers, especially those grasping the sample tube, have reduced but failed to eliminate the rates of such injuries. In one typical Red Cross blood collection center, for example, there are about 10 to 12 needlestick injuries annually out of a total staff of 165 individuals who are in fact using such a prior art guard device.
There is, therefore, a substantial and real need for means to eliminate the needlestick hazard and its actual threat to the health of medical workers in blood collection operations.
Concomitant to the foregoing, ease of fabrication, simplicity of assembly, and reliability of function are prime requisites of devices and equipment in the healthcare arts. To this end, the present invention embraces improved and reliable needle-carrying and manipulating elements, and modes of fabrication and assembly thereof.